Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT07556991

Prospective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma.

Led by University of Rostock · Updated on 2026-04-29

164

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic subdural hematoma (cSDH) is a very common disease, primarily affecting older people, and is associated with significant morbidity and mortality. The incidence described in the literature is approximately 5 per 100,000/year, but it occurs more frequently in the elderly, with up to 58 per 100,000/year. The recurrence rate is high and is described in the literature as 10 to 27%. Consequently, various studies have evaluated potential risk factors for hematoma recurrence, such as age, brain atrophy, mixed HU density in CCT, increased body mass index, and bilateral hematomas. The pathomechanism of recurrence is currently unknown. The mechanism of development after minor trauma and the progression of the hematoma to a symptomatic form remain unclear. A recent retrospective investigation submitted for publication by the applicant, regarding the occurrence of a low-grade infection in patients with recurrent hematomas, examined this as a possible cause. In this study, microbiological swabs were taken from the subdural space after hematoma evacuation. It was shown that a low-grade infection could be detected in approximately 30% of all hematoma recurrences. This is previously unknown in the neurosurgical literature. This raises the question of whether a low-grade infection is already present in the primary chronic subdural hematoma.

CONDITIONS

Official Title

Prospective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be older than 18 years
  • Require surgical treatment for chronic subdural hematoma
Not Eligible

You will not qualify if you...

  • Current or prior antibiotic treatment
  • Presence of infection
  • Recurrent chronic subdural hematoma
  • Chronic subdural hematoma treated without surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UnIversity Medical Center Rostock

Rostock, Germany, 18057

Actively Recruiting

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Research Team

D

Daniel PD Dr.med.habil. Dubinski, MD MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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